In Vitro Analysis of Human Urine With the CloudCath Device

This is a multi-center feasibility study to assess the in vitro function of the CloudCath Device that is being developed to derive clinically-relevant information from the optical characteristics of urine.

Study Overview

• Status: Suspended
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Diagnostic test: Spectral characteristics assessment

Detailed Description

Specimens will be obtained from participants with indwelling catheters in hospital or home settings, who are suspected to be at high risk for urinary tract infection.

To evaluate the performance of the CloudCath Device in repeated measurements over time, multiple specimens may be obtained from the same patients over multiple days or months.

Each sample will be divided into multiple aliquots. One part will be analyzed using the CloudCath Device and reference devices. Another part may be submitted to an independent lab for standard analytical tests.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico
      • CloudCath Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with indwelling urinary catheters

Description

Inclusion Criteria:

• provide a signed informed consent
• patient has an implanted urinary catheter (i.e., Foley, Texas, ureteral)

Exclusion Criteria:

• any condition that the investigator feels may confound the study results or place the participant at risk by participating in the study
• currently taking antibiotics for any reason other than for treatment of urinary tract infection (UTI)
• suprapubic bladder catheter implanted

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UTI-high risk patients; patients who are at high risk for developing a urinary tract infection (UTI).	Diagnostic test: Spectral characteristics assessment; Urine sample analysis for evidence of urinary tract infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spectral characteristics of urine specimens	A quantitative analysis of the spectral properties of the urine specimen using a proprietary algorithm that results in a quantitative CloudCath Turbidity Score (0-100, with higher values indicating more turbidity).	During the period of time that the patient is catheterized (expected to be up to ~1 week)

Collaborators and Investigators

• Sponsor: CloudCath
• Investigators: Study Director: Ben Briggs, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2021
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Tract Infections
• Other Study ID Numbers: CC-L-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes